Global Regulatory CMC Manager

Summary:

• The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle.
• Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities.
• The team also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions.
• The team also supports Medical Information to build/maintain databases to address external questions regarding drug products.
• The GRS-CMC Manager is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses and background packages (including participating / leading HA meetings with support); and/or post-approval submissions.
• In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS), Global Product Development and Supply (GPS) and/or Cell Therapy Development Operations (CTDO).
• The GRS-CMC Senior Manager II will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Responsibilities:

• Support project teams (e.g. TPT / CMC, GRT, TTT, MLT, GO Team, etc.) for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions
• Provide strategic CMC regulatory expertise for development project teams
• Provide strategic input to development and GO teams to mitigate drug supply issues
• Interpret global regulations and guidance
• Identify, communicate and propose resolution to routine issues
• Participate in product fact finding meetings with supervision
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics
• Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success
• Provide technical teams insight into regulatory health authority expectations
• Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success
• Ensures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)
• Support the preparation of CMC policies and procedures
• Utilize electronic systems for dossier creation and tracking

Qualifications:

• Minimum BA/BS Degree
• 4-6+ years pharmaceutical or related experience (min BA/BS). 4+ years of CMC regulatory or related experience
• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, cell therapy during development and post-approval as applicable
• Knowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicable
• Demonstrated ability to develop/maintain strong working relationships cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
• Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness
• Ability to interpret global regulations and guidance documents
• Demonstrated ability to be solution-oriented
• Seeks multiple perspectives and listens openly to others’ points of views
• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
• Demonstrates ownership of results within (and beyond) area of responsibility
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved
• Search for opportunities for continuous improvement
• Strong oral and written skills
• Proficient with electronic systems
• This position may require up to 5% of travel